140.634.81 Non-Inferiority and Equivalence Clinical Trials
- 3rd term
- 2 credits
- Academic Year:
- 2012 - 2013
Students must take or have taken Introduction to Online Learning; good understanding of clinical trials (examples: Principles of Epidemiology [340.601] or equivalent, Statistical Reasoning I-II [140.611-612] or equivalent); Biostatistics in Medical Product Regulation (140.633) or equivalent
Presents the important differences between superiority trials and those intended to show either equivalent effect, or to show that one therapy is no worse than another (but might be better). Explores the problems of setting equivalence margins, preservation of some proportion of active control effect, and emphasizes the use of confidence intervals to interpret the results of studies. Discusses special issues of quality of the trial conduct, assay sensitivity, historical evidence of treatment effects and assumptions of constancy of treatment effects over time. Compares sample size requirements between superiority trials, equivalence trials and non-inferiority trials. Discusses the use of different analysis populations (ITT and per-protocol) and issues of changing conclusions between non-inferiority and superiority. Discusses the regulatory aspects of trial design and interpretation, and reviews existing regulatory guidance.
- Learning Objectives:
- Define “superiority,” “equivalence” and “non-inferiority” clinical trials.
- Assess the adequacy of published examples of equivalence and non-inferiority trials
- Design equivalence and non-inferiority trials, knowing what special features are required
- Present results from trials so that equivalence or non-inferiority can be adequately interpreted
- Methods of Assessment:
Open-book online examination
- Instructor Consent:
No consent required
- Jointly Offered With:
- Special Comments:
Course is pass/fail only, no letter grades. Students must have access to appropriate web tools to take on-line lectures, quizzes (which constitute 15% of the total grade) and exam, and to take part in LiveTalks.